Abstract
Purpose :
Noninfectious uveitis that affects the posterior segment (NIPU), that includes intermediate, posterior and panuveitis, is treated with intraocular, periocular or systemic corticosteroid and/or systemic immunomodulatory drugs. Herein, we report the 3-year safety and efficacy results from a prospective, randomized, double-masked phase 3 clinical trial of FAi to treat NIPU.
Methods :
Subjects with a > 1y history of recurrent NIPU, who had experienced at least 2 separate recurrences requiring ≥ 3m systemic therapy or ≥ 2 intra- or periocular steroid injections, were randomized to treatment with FAi or sham injection. The primary efficacy endpoint was recurrence of uveitis, defined as 1) ≥ +2 increase in vitreous haze; or 2) ≥ 15 letter loss of VA; or imputed in case of rescue treatment for ocular inflammation or missing data. Visual acuity and macular thickness/edema were secondary efficacy outcomes. Safety results included rates of adverse events including, but not limited to, cataract and elevated IOP.
Results :
129 eyes, 87 FAi and 42 sham, were enrolled at 33 sites in the US, Europe, Israel and India. During the 3-year study, the recurrence rates in FAi treated eyes (27.6%, 47.1% and 56.3%) were significantly lower than in eyes randomized to sham (85.7%, 92.9% and 92.9%) at 12, 24 and 36 months respectively, p<0.001. Visual acuity gains of 3-lines were more common with FAi treatment (33% vs 15%) and losses were more common in the sham group (9% vs 1%) at the 3-year visit. Macular edema was resolved in 85% (34/40) of FAi and 70% (16/23) of sham eyes at 36M. During the 3-year study, 42% and 33% of FAi and sham subjects required IOP lowering drops and 6% of eyes in the FAi group and 12% in the sham group required IOP lowering surgery. Cataract surgery was performed on 74% and 24% of phakic study eyes in the FAi and sham groups respectively.
Conclusions :
Study eyes in the FAi treatment group had a reduced rate of NIPU recurrence and a higher rate of macular edema resolution than the sham treatment group. As expected, cataract requiring extraction was a more frequent adverse event in the FAi-treated group.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.